Status:
COMPLETED
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
KEMRI-Wellcome Trust Collaborative Research Program
University of Oxford
Conditions:
Neonatal SEPSIS
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE2
Brief Summary
Neonatal sepsis has a high risk of morbidity and mortality. The current WHO and national guidelines recommend antibiotics to which resistance is reported in neonatal populations, although the availabl...
Detailed Description
Antimicrobial resistance (AMR) has become a major issue in global health. Despite progress in the reduction of under 5 mortality rates in recent decades, the proportion of neonatal deaths occurring wi...
Eligibility Criteria
Inclusion
- Age 0 to 28 days inclusive
- Weight \>1500g
- Born (an estimated) \>34 weeks gestation (calculated as per the Ballard Maturational Assessment)
- Admitted to hospital and eligible to receive IV antibiotics, according to national guidelines
Exclusion
- Baseline sodium level \>= 150mmol/L
- Baseline creatinine \>= 150 micromol/L
- Presenting with severe (grade 3) Hypoxic Ischaemic Encephalopathy (HIE), defined as per Sarnat and Sarnat as a stuporous, flaccid infant (with or without seizure activity) with suppressed brainstem and autonomic functions and absent reflexes
- Requiring cardiopulmonary resuscitation on admission
- Jaundice requiring exchange transfusion
- Admitted as a transfer after an overnight inpatient stay at another hospital
- Known allergy or contraindication to fosfomycin
- A specific clinical indication for another class of antibiotic (other than the nationally recommended standard-of-care)
- More than 4 hours after initiating ampicillin plus gentamicin (one dose), which allows for administration of these first-line antibiotics not to be delayed by study procedures
- Concurrent participation in another clinical trial
- Attending clinician's judgement that the child is so severely ill that adequate communication about the study with the parent or legal guardian is not possible.
- Not planning to remain resident in the County for the next 28 days.
- Lack of consent
Key Trial Info
Start Date :
March 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03453177
Start Date
March 15 2018
End Date
May 24 2019
Last Update
February 17 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
KEMRI / Wellcome Trust Research Programme
Kilifi, Kenya, 80108